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RECRUITING
NCT07501455
NA

Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis

Sponsor: Kenvue Brands LLC

View on ClinicalTrials.gov

Summary

This study is a six-week, double-blind, randomized, parallel-group controlled clinical study. The objective of this study is to evaluate the changes to the oral microbiome, inflammatory mediators, gingival health indices and to assess oral tolerance after 4 weeks of twice daily use of differing oral hygiene regimens including mouthwash compared to a control group. A follow-up assessment will be completed 2 weeks after cessation of treatments.

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

250

Start Date

2026-02-26

Completion Date

2026-05-05

Last Updated

2026-03-30

Healthy Volunteers

Yes

Interventions

OTHER

Distilled Water

Subjects will brush and rinse with distilled water twice daily.

OTHER

Marketed Comparator 1

Subjects will brush and rinse with their assigned mouthwash twice daily.

OTHER

Marketed Comparator 2

Subjects will brush and rinse with their assigned mouthwash twice daily.

OTHER

Prototype Rinse 1

Subjects will brush and rinse with their assigned mouthwash twice daily.

OTHER

Prototype Rinse 2

Subjects will brush and rinse with their assigned mouthwash twice daily.

Locations (1)

The ADA Forsyth Institute

Somerville, Massachusetts, United States